Detector-C: A Blood-based IVD with High Sensitivity and Specificity for Early Detection and Screening of Colorectal Cancer
A Rosenthal, H Köppen, R Musikowski, R Schwanitz, J Behrendt, U Göbel, S Menzel, W Pommerien, H Grümmer, D Nürnberg, H Wichmann, M Pross, J Pertschy, P Nartschik, T Manger, B Unger, R Mantke, T Steinmüller, K Ridwelski, T Buthut, U Fleck, K Gellert, U Hildebr… · Zeitschrift für Gastroenterologie · 2010 · Heft 08
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Zusammenfassung
Introduction and Aims: Colonoscopy is the gold standard for screening of colorectal cancer (CRC). However, only 5% of the screening population aged 55–75 years use colonoscopy per annum due to its inconvenience and invasive nature. There is a need for an accurate, noninvasive blood-based molecular IVD test. Methods: We randomized 572 PAX-RNA blood samples from two prospective, multicentre clinical studies. CRC cases originated from the MSKK study, controls from the CRC.SCR.2 study which enrolled healthy individuals from a screening population undergoing colonoscopy. Blood was drawn prior to surgery or prior to c…